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Higher Dose/Frequency Rebif (Interferon beta-1a) Provides Significant Reduction In Frequency Of Multiple Sclerosis Relapses In Patients Who Convert From Avonex: Presented at ENS

New data presented today at the 13^th Meeting of the European Neurological Society

GENEVA, SWITZERLAND, ROCKLAND, MA, and NEW YORK, NY -- June 18, 2003 -- Patients who converted from Avonex® (interferon beta-1a, 30 mcg once weekly) to higher dose, higher frequency Rebif® (interferon beta-1a, 44 mcg three times weekly), showed a significant reduction in frequency of relapses and MRI lesion activity, Serono, S.A. and Pfizer Inc announced today at the 13^th Meeting of the European Neurological Society (ENS) in Istanbul, Turkey.

At the conclusion of the comparative phase of the EVIDENCE study, patients randomized to Avonex were offered Serono's multiple sclerosis therapy, Rebif. Approximately 73% of Avonex patients (n=223) chose to convert to Rebif. During the six months Following their change in therapy, these patients experienced a 50% relative reduction in the frequency of relapses (0.6432 vs. 0.3216 annualized rate; p<0.001) and a 22% relative reduction in MRI lesion activity (mean number of T2 active lesions per patient per scan; 0.9 vs. 0.7; p=0.022) compared to the previous six months. The exact relationship between MRI findings and clinical outcomes for patients is unknown.

"Patients who converted from Avonex to Rebif in the non comparative phase of the Evidence study experienced improvement in both relapses and MRI lesion activity that is both clinically meaningful and statistically significant," said Dr. Mohammad K. Sharief of Guy's Hospital, London, a clinical researcher presenting the data for the EVIDENCE study group at the ENS Meeting. "These data provide valuable information for people with relapsing forms of MS and their physicians in determining whether a change in therapy would be beneficial. Furthermore, these findings support the results of the comparative phase of the EVIDENCE study."

The EVIDENCE study, which involved 677 patients with relapsing remitting MS, was designed to compare the proportion of patients who were treated with either Rebif (44 mcg three times weekly, subcutaneously) or Avonex (30 mcg once weekly, intramuscularly) who remained relapse-free after 24 weeks (primary endpoint) and 48 weeks of therapy. The results showed that patients treated with Rebif were significantly more likely to remain relapse free at 24 and 48 weeks than were patients treated with Avonex. In addition, patients taking Rebif had fewer active lesions per MRI scan for all studied activity measures and there was an approximate one-third relative difference in favor of Rebif for measures of MRI lesion activity.

No new safety issues were noted in the cross-over extension phase of the EVIDENCE study. Patients converting from Avonex to Rebif, as expected based on increased dose and frequency of subcutaneous administration, experienced an increase in interferon related side effects. These included injection site reactions and in asymptomatic changes in white blood cell counts and liver function tests. Discontinuation due to adverse events was 5.8%, which is similar to discontinuation due to adverse events for patients on Rebif during the comparative phase of the EVIDENCE study.

Additional Information

Multiple sclerosis is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. MS may affect approximately two million people worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Rebif (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system, fight disease and reduce inflammation.

Rebif was approved in the US on March 7, 2002, for the treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability. Rebif, which is co-promoted in the United States by Serono and Pfizer Inc, is the only drug to gain exception to the marketing exclusivity provision of the Orphan Drug Act based on superior efficacy. The Orphan Drug Act, enacted in the US in 1983, provides drug makers with commercial incentives to encourage the development of treatments for patients with rare and debilitating diseases. Rebif was approved in Europe in 1998 and is registered for use in more than 70 countries worldwide.

US residents can find more information about Rebif in the full prescribing information, on line at www.mslifelines.com or by calling MS LifeLines™ at 1-877-44REBIF. Patients should be instructed to read the Medication Guide accompanying the product. Most commonly reported side effects are injection site disorders, flu-like symptoms, elevation of liver enzymes and blood cell abnormalities. Rebif is contraindicated in patients with hypersensitivity to natural or recombinant interferon, human albumin, or any other component of the formulation. Female patients should be informed of potential hazards to a pregnancy; discontinuation should be considered if pregnancy occurs. Patients, especially those with depression, seizure disorders, or liver problems, should discuss with their doctor whether Rebif is right for them.


SOURCE: Pfizer, Serono

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